(WCBS 880) — Moderna announced Tuesday that it has started giving doses of its COVID-19 vaccine to children as young as six months old as part of a new study.
The drug company expects to enroll 6,750 healthy pediatric participants ages 6 months to under 12 years in the U.S. and Canada as part of the second phase of its KidCOVE study, which is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
“It is humbling to know that 17.8 million adults in the U.S. have received the Moderna COVID-19 Vaccine to date. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” said Stéphane Bancel, Chief Executive Officer of Moderna.
The study will evaluate the safety, tolerability, reactogenicity and effectiveness of the vaccine in young children.
Participants will receive two doses given 28 days apart in the two-part study.
Those ages 2 to less than 12 years may receive one or two dose levels (50 or 100 micrograms) while those ages six months to under 2 years may receive one of three dose levels (25, 50 or 100 micrograms) for the first shot.
According to the New York Times, the lower dose will be administered first and the effects monitored before later participants receive the higher dose.
An interim analysis will examine the safety and efficacy of the shots to determine which will be used for the second dose. In the second part of the study, participants will receive the selected dose or a placebo.
Participants of the study will be followed for a year.
“Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population,” the company said. “Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study.”
The vaccine is being tested in older children, ages 12 to 17, in a separate study.